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A First in Human Study to Evaluate Safety, Tolerability, and Pharmacology of PF-06826647 in Healthy Subjects and Subjects With Plaque Psoriasis

Study Purpose

This first in human study will evaluate the safety, tolerability, pharmacokinetics (PK), and
pharmacodynamics (PD) of PF-06826647 in healthy subjects and subjects with plaque psoriasis.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers

Yes

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Study Type

Interventional

Eligible Ages

18 Years - 55 Years

Gender

All

More Inclusion & Exclusion Criteria

Healthy Participants:

Inclusion Criteria:

- Healthy male subjects between ages of 18-55 years
- Healthy female subjects of non-childbearing potential between the ages of 18-55 years
- Body Mass Index (BMI) of 17.5 to 30.5kg/m2; and a total body weight >50kg (110lbs).

- No evidence of active or latent or inadequately treated infection with Mycobacterium
tuberculosis (TB)
- (Optional) Japanese subjects who have four Japanese biologic grandparents born in
Japan

Exclusion Criteria:

- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at time of dosing)
- Pregnant female subjects; breastfeeding female subjects; female subjects of
childbearing potential
- Fertile male subjects who are unwilling or unable to use a highly effective method of
contraception as outlined in this protocol for the duration of the study and for at
least 28 days after the last dose of investigational product
- Have a clinically significant infection currently or within 6 months of first dose of
study drug
Psoriasis Participants:

Inclusion Criteria:

- Healthy male subjects between ages of 18-65 years
- Healthy female subjects of non-childbearing potential between the ages of 18-65 years
- Have a diagnosis of plaque psoriasis for at least 6 months prior to first study dose
- Have plaque-type psoriasis covering at least 15% of total body surface area (BSA) at
Day-1(prior to randomization in the study
- No evidence of active or latent or inadequately treated infection with Mycobacterium
tuberculosis (TB)

Exclusion Criteria:

- Currently have non-plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular
psoriasis
- Have a clinically significant infection currently or within 6 months of first dose of
study drug, or a history of chronic or recurrent infectious disease
- Pregnant female subjects; breastfeeding female subjects; female subjects of
childbearing potential
- Fertile male subjects who are unwilling or unable to use a highly effective method of
contraception as outlined in this protocol for the duration of the study and for at
least 28 days after the last dose of investigational product

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

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